Lexicon Pharmaceuticals (NASDAQ:LXRX) Q2 2020 Earnings Call

0:00 Welcome to the Lexicon Pharmaceuticals Second Quarter 2020 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. Following managers' prepared remarks, we will hold a question and answer session. As a reminder, this call is being recorded today, July 30, 2020. I will now turn the call over. to Kim, Dr. Kimberly Lee, Head of Investor Relations and Corporate Strategy. Please go ahead.

0:33 Thank you, Crystal. Good morning and welcome to the Lexicon Pharmaceuticals Second Quarter 2020 Financial Results and Business Update Conference Call. Joining me on today's call are Lynelle Coates, Lexicon's President and Chief Executive Officer, Alex Santini, Executive Vice President and Chief Commercial Officer, Dr. Pablo La Puerta, Executive Vice President and Chief Medical Officer, Dr. Praveen Tile, Executive Vice President of Research and Development, and Jeff Lloyd, Executive Vice President of Corporate and Administrative Affairs and Chief Financial Officer. After formal remarks, we will open the call-up for Q&A. Earlier today, Lexicon issued a series of press releases, one announcing our financial results for the second quarter of 2020, Thank you so much for joining us.

1:45 and in the case of the financial results and asset sales press releases through our SEC filings. A webcast of this call along with a slide presentation will be accessible in the investor relations section of our website. During this call, we will review the information provided in the releases, provide an update on our clinical programs and then use the remainder of our time to answer your questions. Before we begin, let me remind you that we will be making forward-looking statements, including statements relating to the safety and efficacy and the therapeutic and commercial potential of LX9211, Dermelo, Cetagliflozin, and our other drug candidates. These statements may include characterizations of the commercial performance of Dermelo, the expected timing and results of clinical trials of and our other drug candidates and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, strategic alliances and intellectual property, as well as other matters that are not historical facts or information.

2:58 Various may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include insurgencies related to our ability to complete the sale of Zermelo, the timing and results of clinical trials and preclinical studies of LX9211 and our other drug candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protections for our discoveries, limitations imposed by patents owned and controlled by third parties, and the requirements of substantial funding to conduct our research, development, and commercial activities. For a list and a description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. I would now like to turn the call over to our President and CEO, Lynell Coates.

3:47 Thank you, Kim, and good morning to everyone, and thanks for joining us on the call today. I mean, today's presentation will be made on behalf of all the extraordinary men and women here at Lexicon who work tirelessly every day to advance our science into the hands of patients. So let me jump in and talk about our second quarter. We made very good progress on Zamello business and our pipeline while effectively managing our resources and spending. I will elaborate on some of the key achievements and will then turn the call over to Jeff and Praveen for updates on our financial results and pipeline developments, respectively. Starting with Zomelo, we achieved U.S. net sales of $9 million in the second quarter of 2020. That's up 21% from the corresponding period in 2019.

4:34 Earlier this morning, we announced that we entered into an agreement with Tessera Therapeutics for the sale of Zomelo and related assets. Tessera will pay Lexicon approximately $159 million in cash at closing, which includes $155 million upfront payments. and approximately $4 million for existing inventory. Lexicon may receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of telotrastate ethyl in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales as a mellow in biliary tract cancer. As part of the transaction, CSERA has agreed to assume the currently ongoing tele-ABC Phase II clinical study of Zamello in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to Zamello.

5:34 The transaction is expected to close in the third quarter of 2020, subject to the satisfaction or waiver of customary closing conditions. This transaction allows us to rely and other early stage candidates. This also allows us to efficiently use our resources and importantly, significantly reduce our debt, including the full repayment of our $150 million secure term loan. Jeff will talk more about this later. We ended the second quarter with approximately $202 million in cash and short-term investments, and we continue to prudently manage our balance sheet.

6:23 With that, I'll now turn the call over to Jeff.

6:28 Thank you, Lionel. To begin, I will discuss key aspects of our second quarter 2020 financials. More financial details can be found in our Form 10-Q, which was filed yesterday evening. Now, please refer to slide five of our presentation. As indicated in our press release today, revenues for the second quarter decreased to $9.2 million from $9.7 million for the corresponding period in 2019. This was primarily due to an absence in this year's quarter of both tablet sales of Zermelo to Epson and a decrease in collaborative revenues, partially offset by an increase in U.S. net product sales. Net product revenues for the second quarter of 2020 were $9 million from net sales of Zermelo in the U.S., up 21% over the prior year quarter.

7:20 Cost of sales related to sales of Zermelo for the second quarter of 2020 was $0.7 million compared to $1.3 million in the prior year quarter. Research and development expenses for the second quarter increased to $57.3 million from $12.6 million for the corresponding period in 2019, primarily due to increases in external clinical development costs relating to Sotagliflozin subsequent to the termination of the Sanofi Alliance. Selling, general, and administrative expenses for the second quarter were $14.1 million compared to $14.3 million for the same period in 2019. Net loss for the second quarter was $69.1 million, or 65 cents per share, as compared to a net loss of $23 million, or 22 cents per share, in the corresponding period in 2019.

8:14 For the second quarter of 2020, net loss included non-cash stock-based compensation expense of $4.3 million. For the second quarter of 2019, net loss included non-cash stock-based compensation expense of $3.8 million. We ended the second quarter of 2020 with $201.9 million in cash and short-term investments, as compared to $271.7 million as of December 31, 2019. The effects of the Zermelo sale and corporate realignment on expenses will be reflected in an upcoming Form 8K, but I can say that this transaction will extend our financial runway. Turning to our financial guidance for 2020, we are revising our 2020 operating and R&D expense guidance that was previously communicated on our last earnings call with the understanding that we'll provide further updates following the closing of the Tercera agreement.

9:11 We are reducing total operating expenses to be in the range of $230 to $250 million, down from $235 to $255 million. We expect R&D expenses to be in the range of $175 to $185 million, down from $180 to $190 million. Notably, we will have meaningfully higher R&D expenses in the third quarter than we will have in the fourth quarter, as we come much nearer over the course of the third quarter to completing the windup of the Sotagliflozin Type 2 Diabetes Program and Outcome Studies. We continue to expect SG&A expenses for the year to be in the range of $55 to $65 million. We expect non-cash expenses to be approximately $24 million of our total operating expenses, up from $22 million due to the impairment loss on buildings that we recorded this quarter.

10:06 Finally, Santa Fe committed to pay Lexicon $260 million under the terms of the settlement agreement ending that collaboration. Of that total, the first installment in the amount of $208 million was paid in September of last year. The second installment in the amount of $26 million was paid in March, and the final installment in the amount of $26 million is payable this September. The $52 million in payments this year will not affect this year's revenues because the full revenue impact of the settlement was recorded in 2019, but they will obviously benefit our 2020 cash flow. As Lionel mentioned earlier, the divesting of Zomelo now allows us to focus on our R&D pipeline.

10:51 We are extremely excited about our most advanced candidate, LX9211 for neuropathic pain, for reasons that we will delve into shortly. This drug candidate is a potent, highly selective, oral small molecule inhibitor of adapter protein 2 associated kinase, or AAK1. AAK1 is a target that we discovered and extensively characterized in a drug discovery alliance with Bristol Myers Squibb and we hold exclusive development and commercialization rights for LX9211. Neuropathic pain is a lesion or disease of the somatosensory nervous system and can manifest itself in painful conditions like diabetic peripheral neuropathic pain.

11:36 Up to 17% of the general population worldwide has chronic neuropathic pain, and about 33% of global opioid sales are for neuropathic pain, with these sales growing at an estimated compound annual growth rate of 2.5%. You can appreciate that this fact alone demonstrates the significant unmet need in neuropathic pain, but the unmet need extends to non-opioid drugs as well, where limited efficacy and dose limiting tolerability is a problem. There is a tremendous need in the field for drugs with better efficacy and fewer side effects. Neuropathic pain is a field in which very few novel mechanisms of action have been introduced or even are under investigation in which there is far less innovation and competition than in fields like cancer. Even so, last year the neuropathic pain market worldwide reached nearly $6 billion.

12:31 Diabetic peripheral neuropathic pain, or DPNP, is one of the most common types of neuropathic pain, accounting for about 20% of drug sales for neuropathic pain. It is a condition that involves damage to the peripheral nervous system caused by hyperglycemia and other diabetes-related factors. DPNP can involve pain of numbness, tingling, burning, sharp, and dull ache, which are often localized to the extremities having an impact on the feet and hands. The prevalence of this condition is expected to grow significantly at a nearly 4% annual growth rate, driven mainly by the increasing prevalence of diabetes. An estimated between 60 and 70% of people with diabetes eventually develop DPNP.

13:18 There are only four approved therapies for DPNP, and outside of these drugs, the market consists of off-label use of tricyclic antidepressants and opioids. Current treatment options are limited by a lack of efficacy, side effects, and abuse potential. The burden on the healthcare system is also significant, with an estimated annual expense of managing DPNP being four times more than the cost of managing diabetes alone. So there remains a definite need for a therapeutic option like LX9211 that has a novel opioid independent mechanism of action, an excellent safety profile, and ease of use with once daily dosing. As you may recall, our scientific platform has enabled us from physiology and genetics to drive drug discovery, and we are proud to say that LX9211 originated from this platform.

14:11 The platform involved assessment of the functions of almost 5,000 genes over a broad range of physiology and behavior to identify drug targets with compelling biology specific to an effect that would be desirable for treating disease without target-related side effects. It was from the Genome 5000 program that AAK1 knockout mice were first discovered to have a phenotype indicating resistance to neuropathic pain, as seen in these study results. Our initial screen identified results in the second phase of the formalin-PA model, which was the initial signal of potential for inflammatory or neuropathic pain. Our subsequent research employed a more rigorous assessment using the spinal nerve ligation model, which assesses pain behavior based on the equivalent of a pinched or compressed nerve. Both models showed compelling results, standing out in terms of efficacy as a uniquely compelling neuropathic pain target in our in vivo assessment of the functions of almost 5,000 genes and for which knockouts were healthy and demonstrated no other real phenotype apart from pain resistance.

15:20 We actually have two development candidates for this mechanism of action of different chemotypes that originated from intensive work conducted over a number of years by teams of chemists and biologists from both Lexicon and Bristol Myers Squibb in a joint neuroscience alliance. Both drug candidates have successfully completed IND-enabling studies, with LX9211 being taken into clinical development and the other candidate IND-ready. As VMS moved out of neuroscience and focused more on immuno-oncology, Lexicon obtained rights to the full program, including full development and commercialization rights to LX9211. I will now turn the call over to Rabin, who will highlight the data underlying this very exciting program, and specifically the data supporting LX9211 and its development.

16:13 Thanks, Jeff. This has been a very exciting journey for us. discovering LX9211's potential in preclinical models and now bringing it to the clinic. As shown on this slide, we studied LX9211 in multiple models, including streptozotocin-induced DPNP models in rats and the varicella zoster rat model of postherpetic neurologia. As you can see, mechanical allodynia, which is a measure of pain, saw the greatest reduction at one milligram and three milligram per kilogram of LX9211, reducing pain up to 65% in diabetic animals. Reduction in neuropathic pain behavior was also seen after a single dose and after seven daily doses of LX9211 following a viral infection in the varicella zoester rat model.

17:11 Moving on to slide 14, We also have compelling preclinical data in rodents that suggest the potential of LX9211 to avoid dose-limiting side effects such as motor impairment seen with standard of care like gabapentin and pregabalin. Slide 15 shows our mechanistic work in preclinical models, which has drugs' unique properties associated with its mechanism. We have identified that LX9211 acts at the spinal dorsal horn as demonstrated by efficacy in neuropathic pain models via intrathecal delivery.

17:57 In nerves of injured rats, there was a reduction in spontaneous firing of the spinal dorsal horn neurons with AAK1 inhibitor treatment. Non-CNS penetrant inhibitors did not show efficacy in these neuropathic pain models. We also saw that LX9211's mechanism was independent of the opioid pathway, and we believe the mechanism may involve alpha-2 heteroceptor pathways, but AAK1 inhibitors are not antagonists or modulators of these heteroceptors. In summary, Preclinical data demonstrated LX9211's ability to penetrate the CNS well, reduce pain behavior in models of neuropathic pain, and have a mechanism of action that is independent of opioid pathway, which we all can agree is an extremely important trait.

18:57 On slide 16, you can see that based on favorable preclinical data, we advanced LX9211 into phase one single and multiple dose studies. Results supported our preclinical work, demonstrating a favorable pharmacokinetic profile which supports once-daily dosing with a good safety profile. On slide 17, I'm happy to disclose that we have initiated patient screening in RELIEF DPN-1, which is a phase two randomized placebo-controlled multicenter clinical study of LX9211 for the treatment of DPNP that is expected to enroll approximately 300 patients at 30 U.S. clinical sites.

19:45 The primary efficacy endpoint under evaluation in this study is the change from baseline at day one to week six in average daily pain score, or ADPS, based on an 11-point numerical rating scale. We look forward to making continued progress on this program and reporting to you. We are currently preparing for additional phase two studies of LX9211 and other areas of neuropathic pain based on the promising results in multiple preclinical models of neuropathic pain that I just shared with you and based on favorable phase one clinical safety profile, both in single and multiple dose studies. We plan to initiate a proof of concept study in post-herpetic neurology in the fourth quarter of this year.

20:35 I will now turn the call over back to Linnell. Linnell? Ravine, thank you.

20:41 Jeff, thank you. I would just conclude by saying we're extremely excited about this compound. Always have been. I think a few years ago at J.P. Morgan, I was asked, you know, what am I most excited about that we're working on at Lexicon. I signal to people, keep an eye on our AAK1 target. And here we are today. We have I've gotten through phase one. Our confidence has grown in phase two. And now we're going to build our efforts around this compound and what can come from it. Because I truly believe this is one of those compounds that you can ultimately build a franchise around with multiple indications within the neuropathic pain space. So we will look forward to sharing more information with you as we, you know, see getting through phase two.

21:30 as Praveen has laid out, and then start our work in our second planned study for post-hepatic neuralgia. With that being said, I also want to take this opportunity and just really thank the extraordinary commercial team, medical team, and our field team who supported Zamello and got it to a place where it was remarkably successful in the marketplace and put it in the position where a company like Tessera that has a and a portfolio of oncology assets that will find a very good home that could be well supported relative to the patient support that we've created in the marketplace and the value that I believe that they can add as we go forward. With that, the milestones I think you can look forward to is the closing of the TSERA transaction, which we believe will conclude in Q3.

22:23 And as we've already mentioned here, the dosing of the first patient in the Phase II program for DP-NP would be a Q3 opportunity. And then we will initiate our Phase II study in post-hepatic neuralgia in Q4. With that, I'll say thank you and turn the call over to the operator to start Q&A. Thank you. As a reminder, if you would like to ask a question, please press star 1 on your touchtone phones. Once again, that is Star 1 to ask an audio question. Your first question comes from the line of Stephen Wiley with Stiefel.

23:01 Yeah, good morning. Thanks for taking the questions. Can you maybe just confirm that the intended repayment of the term loan is a byproduct of a coveted trip related to the transfer of Zermelo? And then... I believe the term loan also has, you know, kind of the usual make-whole and prepayment premiums. Can you disclose what those are?

23:31 Jeff, I'll turn it over to you.

23:35 Yeah, so we are, I mean, part of the reason for doing the transaction was to reduce our debt. And so our intention is to use the proceeds to fully repay the term loan and that was part of the intent of the transaction. So this is more of an intent to pay down the loan rather than having to pay off the loan because of the transaction. There will be a modest prepayment penalty associated with this repayment but we expect the The proceeds of the deal to cover the full repayment of the loan, including the prepayment penalty associated with it.

24:25 Okay. And then just on 9211, can you maybe just give us a broad estimate of the cost associated with the two trials that you're planning to initiate, when we might see some initial data emerge out of these trials, and then Some color around the intellectual property of the asset. I know that this was part of a 2009, I think, collaboration with Bristol. So any commentary on those fronts would be helpful.

25:01 Jeff, I'll turn it over to you. Yeah, sure. So these studies are, you know, the first study is a relatively large study. It's a 300-patient study. The cost of this study is going to be a little north of $10 million from an external perspective. The second study will be a little bit less because it's going to be a smaller study. In terms of the duration, our expectation is to be able to get results back late next year. and in terms of the intellectual property, we discovered and were the first to publish on this target.

25:53 We spent a lot of time before we made any disclosure or publication of the target working on medicinal chemistry and working on the target. We have a number of different compounds that we've covered in terms of patents and this is a highly novel target, highly novel chemistry around which we have good strong patent protection. As I mentioned, we have a couple of different chemotypes for which we have development candidates.

26:29 Okay, so should we think of composition of matter extending into the 2030s or is this kind of a pre-2030 composition and then there's going to be some Dependency upon either a term extension or some method patents?

26:46 It's going to be the extension. Actually, I don't remember the exact term. It will last into the with patent term extension should last into the late 2030s. But it's so that I mean, that should mean that we're kind of early 2030s in terms of patent duration.

27:10 Okay. I'll hop back in with you next. Take any questions.

27:13 Yep. Your next question comes from the line of Alan Carr with Needham.

27:18 All right. Thanks for taking my questions. I guess, can you go a little bit where you think more of the outflows and the inflows with the cashier? I know you had an 8K on your building recently, but can you comment on that? And then also, So the focus, obviously, is 9211 now. You have from your platform, your knockout platform way back when, my recollection is that you had a number of targets to work with. Is Lexicon essentially a 9211 company for the rest of 20 and 2021, or do you expect to be making some announcements around What's behind it? What's next at Lexicon? Thanks.

28:15 Jeff, I'll give you the first part of that question in terms of the AK.

28:24 So we will have some costs associated with this. I think that our customers Our guidance that we're providing is going to be relatively close to where we end up, but we'll provide some updates when we get closer to ending the, or basically closing the transaction. So, you know, in terms of the cost of the of Zermelo, you know, obviously Tercero's going to assume basically the cost of that business going forward. And we're going to not have the revenues associated with that going forward. But our R&D spend is coming down significantly as a result of winding down the Soda Diplosion Program.

29:15 And most of our R&D expenses in the near term are going to be focused on LX9211. I'll let Lanelle talk about some of the other assets because there are other assets that we have and that we will continue to work on.

29:31 Yeah, so let me start with to be very clear about something. We're not giving up on Type 1. So you can fully expect us to go back at it again, probably going into our fourth quarter, re-engaging the FDA on the Type 1 program. And it fits very nicely into what we're talking about here, which is, you know, diabetic neuropathic pain and the associated issues. So it does fit very nicely, should we be successful. At this point, it's a low-cost risk for us to approach the agency, and should we be successful, there's a significant amount of upside should we be successful. So we're not giving up on Type 1, and we should make that note. The second one is that we have a whole line of products that are what we call a 103X project that we're looking in the areas of fibrosis and NASH, that we'll have much more to say about that in the coming year. Then thirdly, we have some early stage work that we're doing in the MedChem space, also in the metabolic area where we think we have a very interesting and novel approach should we be successful with the MedChem. So there's a lot more we have to say going forward now that we are rolling back into a significant portfolio of R&D assets that we have not funded historically as we chase The Diabetes Marketplace and used our cash there.

31:00 But this really gives us an opportunity to begin to open up that portfolio and start to fund it and start to put more shots on goal as a result of having the opportunity to have the cash and place it appropriately in terms of his allocation. So much more to say. So yes, 9211 will be the primary focus for us. going into next year, but it will not be our only focus, and we'll have a lot more to say going into next year about the other assets.

31:30 A clarification, Linnell. You mentioned discussions with the FDA around type 1 diabetes, but what's the status in Europe, and what do you plan to do there? I mean, you have approval over there.

31:47 Yeah, so that remains on hold because that's not where we want to deploy our capital at this moment, but we continue to shift now from this conversation that we just concluded on the cell as a mellow and restart the conversation as COVID starts to become less and less of an issue for us to have conversations in Europe about rights of a product that's approved for type 1 diabetes there. So this is a good opportunity to restart those conversations. As I said before, we were in good place to have those conversations before COVID-19 hit and those conversations pretty much dried up and we had to make different choices.

32:33 But I do think we do have the opportunity now to start to reengage about Europe as an asset. So stay tuned on that one as well.

32:40 If you make progress in the U.S. with the FDA program, Is that something you'd commercialize over here, or is that something you'd partner also?

32:50 No, I think we would commercialize it. No, great question, Alan. We would commercialize it here. It's, you know, the Type 1 marketplace does not require significant commercial deployment. It's more of a specialty-focused market. You don't have to have an army of commercial support to do so. It's a very untapped market in terms of going beyond insulin. So it is a place that we can invest quite nicely that really sets us up for success with LX9211 that will be specifically within the diabetes space for neuropathic pain.

33:29 Okay. Great. Thanks for taking my questions.

33:32 You bet. Your next question comes from the line of Liana Mousatos with Wedbush. Yes, hi, good morning. Thanks for taking our questions. This is Andreas for Liana. A couple to start, actually. Could you guys clarify regarding the Tercera transaction and Zermelo sales? There's no more how you guys are going to monetize the carcinoid syndrome diarrhea. Is that completely sold off? Yes. Okay, good. I know you mentioned that in Alan's question. I just wanted to clarify. Okay, so moving to the Delary track, could you – so you guys are responsible for Phase 2 development. How is the decision to move to Phase 3 made?

34:28 That decision now will be – that decision will be to Sarah's decision. Okay. So at that point, they're going to be press releasing that? Nothing to do with you guys? No.

34:40 At the close of this deal, all those decisions would be Tercera's decisions. Okay. All right. Fantastic. And then just moving back, moving over to LX92-11, you guys are going to read out some data at the beginning of the year, I believe, for the neuropathic pain indication. Have you guys discussed powering or what you guys consider to be a clinically meaningful effect? What are you looking for?

35:10 I'm not sure if we're going to have data that call out the beginning of next year, but Jeff, I'll let you take that.

35:20 So we're expecting to have data in LX9211 towards the end of next year. We're looking at a pain scale and looking at improvement in the pain scale. It's relatively well-powered because it's a large study. It's a 300-patient study, roughly, with with three arms, placebo, and two doses. So we did feel like it was important to do a substantially sized study given the indication. Okay. All right. Thanks. And then just last one on partnership talks in type 2. Ongoing, still a focus? Yes.

36:08 No, we're not having any ongoing conversations in Type 2. We're winding that program down, and if someone certainly has an interest, it'll be ready for filing here in the United States and around the world, but Lexicon is not actively engaged in conversations around soda. Our activity will be actively focused on LX9211 and all of the relative resources it takes to bring that one forward. However, in Europe, as I said before, in the Type 1 space, you have an approved product There is where I think we can have an opportunity to have active discussions as we get on the other side of the COVID-19 situation in Europe. So that's what I would look more forward to. With that being said, this is very fluid, and so interested parties come in and out of the process, and should that happen, we'll certainly let you know.

37:02 Okay. Thanks for taking the question. Once again, in order to ask an audio question, please press star one. Your next question is from the line of Yigal Nakamovitz with Citi.

37:20 Hi, this is for Yigal. Thanks very much for taking your questions and congratulations on all the updates. First, on LX9211, I just wanted to clarify the data that we're looking at potentially at the end of 2021. Will that consist of all 300 patients, or is that more of an interim look?

37:43 Dr. Tile?

37:45 Samantha, Praveen Tile here. It will be the final results for the Phase II DPNP study, which I talked about.

37:56 Got it. And then in the additional study in post-hepatic pain, That one's coming in smaller. Should we expect a similar timeline by the year 2021 for that study as well?

38:10 We are actually, like Lynelle was mentioning, we are going to start that study towards the end of this year. We are in discussion with the clinical research organization, contract clinical research organization, to figure out what sites we are going to use and what is the enrollment rate. So I think in the next quarterly, We should be able to tell you the timelines for completion of that study. But if I was to just guess, it will be very similar timeline as Diabetic Peripheral Neuropathy Pain Study. So towards the end of next year, I would guess.

38:49 Okay, that's helpful. and then I just wanted to maybe get a little bit more background on how diabetics are treated when they develop DPN. I think in your slides you have 60-70% of diabetics develop DPN. What's the typical treatment plan there? If they present with pain are physicians inclined to treat them or is there a threshold for mild disease that maybe goes untreated given opioids and how would you think that Your drugs would be deployed, would it be across mild, moderate, severe, or do you think it could potentially be used mostly in the more severe cases?

39:30 So, I'd just say that the mild patients are often not treated, and it's more moderate to severe patients that are treated. Part of that is to do with the The nature of the treatment, and part of it is because the mild patients can function better without treatment and basically tolerate the pain perhaps better than the treatment itself. Frequently, you see gabapentin and pregabalin being used. Lyrica, until its patent expires, Expired was a very substantial drug and it was anchored in neuropathic pain. And the challenge with those drugs is with pregabapentin and pregabalin is both efficacy, not necessarily working for everyone, and then also having dose-limiting tolerability.

40:37 For patients for whom those don't work, some people are put on opioids, but obviously people are reluctant to use opioids, appropriately reluctant to use opioids to treat a chronic condition like diabetic peripheral neuropathic pain. And so it's a very challenging area. But I would say for now, most of the treatment is in moderate to severe patients, less in the mild patient population.

41:08 Is it known what percentage of patients fall into that mild category?

41:18 It's probably, you know, roughly, you know, roughly a third of the patients are falling in that category. It changes over time.

41:27 Okay, got it. And just last one for me, you know, with the Sarah Deal and payment of a term loan. Looking at your cash runway, is it fair to say that it's sufficient to take you through Phase 2 development, or is that not true?

41:46 Yes, it is fair to say that we should be able to get the cash runway that we have should be able to get us to the Phase 2 results. We had said previously that the operating expenses, that we could fund our operating expenses through the end of 2021, which is the timetable we're talking about here. This transaction is going to extend that runway, so we should be able to get through Phase 2 results in neuropathic pain with our current financial resources.

42:18 Great. Thanks very much for taking the question.

42:21 Yeah, I also would add that it will get us through the – we will manage our cash to get through the Phase 2 for LX9211. but also we will have cash and we'll be able to invest in the programs I talked about, 103X and bringing a candidate forward in terms of filing an IND and the work that we're doing around MedChem on another program for metabolism. So we're projected out to Jeff's point. We can achieve all of the above and extend out through beyond 2021. Thank you.

42:58 That's very helpful, Collar. There are no further questions. I will now turn the call back over to Mr. Coates for closing remarks.

43:09 Well, again, I want to thank everyone for joining us this morning on this call. I hope we've been able to articulate how we're thinking about the future as we restructure our company to start to take advantage of the pipeline that we have and advance our compounds from the clinic to patients. I'm very pleased that Samal has found a very strong home A company that has oncology experience that could invest in it as part of its overall portfolio and ensure that patients have an opportunity to experience Zomello as we have set it up in a very successful way. I also want to thank all of the extraordinary people who have made Zomello possible here at Lexicon. It's bittersweet certainly when something like this happens.

44:00 But at the end of the day, it's the right thing to do to ensure that Zamello receives the kind of attention and investment that's required for it to grow. And I just want to take the opportunity publicly and thank them for all of their tremendous efforts. We look forward to engaging with you to talk more about LX9311 and the rest of Lexicon's pipeline and future calls. Thank you. This concludes today's conference call. You may now disconnect.